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Trial registered on ANZCTR


Registration number
ACTRN12611000183987
Ethics application status
Approved
Date submitted
15/02/2011
Date registered
16/02/2011
Date last updated
23/09/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
Efficacy of continuous preperitoneal infusion of ropivacaine in laparoscopic colorectal surgery
Scientific title
Efficacy of postoperative continuous preperitoneal infusion of 0.5% ropivacaine at 4ml/hr after laparoscopic colorectal surgery compared to intravenous patient controlled postoperative analgesia
Secondary ID [1] 253610 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
This study investigates postoperative analgesic efficacy and recovery in patients receiving continuous preperitoneal ropivacaine infusion vs. intravenous patient controlled analgesia after laparoscopic colorectal surgery. 261170 0
Condition category
Condition code
Anaesthesiology 259324 259324 0 0
Pain management
Oral and Gastrointestinal 259327 259327 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention consists preperitoneal placement of catheter with multiple side-holes to continuously release 0.5%ropivacaine at 4ml/hr for postoperative 72hours. This placement will be conducted by an experienced attending surgeon.

Intervention with 0.5% ropivacaine (local anesthetics) continuous infusion at 4ml/hr
Intervention code [1] 258032 0
Treatment: Drugs
Intervention code [2] 258046 0
Treatment: Devices
Comparator / control treatment
Control : IV PCA regimen includes fentanyl 16 mcg/ml in 100ml saline bag with basal infusion rate of 0.5 ml/hr, bolus of 1ml at 15min lockout interval. Thus maximum dose allowed per hour is 80mcg and basal infusion is continued with bolus injection when patient presses a button. Overall duration of this method is 72 hours postoperatively.
Control group
Active

Outcomes
Primary outcome [1] 262127 0
Decrease in Visual analogue scale (VAS)
Timepoint [1] 262127 0
postoperative 2hr, 6hr, 24hr, 48hr, 72hr
Secondary outcome [1] 273208 0
return of bowel movement (flatus)
Timepoint [1] 273208 0
exact time checking during postoeprative period
Secondary outcome [2] 273209 0
reduced consumption of rescue analgesics
Timepoint [2] 273209 0
postoeprative 2hr, 6hr, 24hr, 48hr, 72hr

Eligibility
Key inclusion criteria
ASA PS 2-3 patients undertaking laparoscopic colorectal surgery
Minimum age
20 Years
Maximum age
65 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
patients with previous opioid analgesic medication
allergic to local anesthetics or opioid
coagulopathy or hemostatic abnormalities
neurologic disorder / mental disorder
obesity BMI > 30

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Patients are randomly allocated to one of two groups by using computer based randomized number concealed in an envelop before intervention. All patients receive preperitoneal wound catheterization and IV PCA (intravenous patient controlled analgesia ) device, but one group with study drug only in preperitoneal catheter and the other group with study drug only in IV PCA. Allocation is blinded both to patients and investigators.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Consecutive patients receiving laparoscopic colorectal surgery will be enrolled with randomization sequence generation using computerized randomizer.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 3199 0
Korea, Republic Of
State/province [1] 3199 0

Funding & Sponsors
Funding source category [1] 258506 0
Hospital
Name [1] 258506 0
Samsung Medical Center
Address [1] 258506 0
50 Ilwon dong, Gangnam gu, 135-710
Samsung Seoul Hospital
Country [1] 258506 0
Korea, Republic Of
Primary sponsor type
Hospital
Name
Samsung Medical Center
Address
50 Ilwon dong, Gangnam gu, 135-710
Samsung Seoul Hospital
Country
Korea, Republic Of
Secondary sponsor category [1] 263756 0
Commercial sector/Industry
Name [1] 263756 0
B. Braun Korea Co., Ltd.
Address [1] 263756 0
13th Fl., West Wing, POSCO Center Bldg. 892, Daechi4-Dong, Kangnam-Ku, Seoul 135-777
Country [1] 263756 0
Korea, Republic Of

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 260480 0
Samsung Medical Center IRB
Ethics committee address [1] 260480 0
50 Ilwon dong, Gangnam gu, 135-710
Samsung Seoul Hospital
Ethics committee country [1] 260480 0
Korea, Republic Of
Date submitted for ethics approval [1] 260480 0
25/10/2010
Approval date [1] 260480 0
13/12/2010
Ethics approval number [1] 260480 0

Summary
Brief summary
This controlled double blinded randomized clinical study intend to investigate postoperative analgesia and bowel recovery thus overall recovery efficacy of continuous preperitoenal infusion of 0.5% ropivacaine compared to intravenous opioid based patient controlled postoeprative analgesia. The main hypothesis of this study is that analgesic method using local anesthetic will provide equivalent or better analgesia with prompt bowel recovery.
Trial website
Trial related presentations / publications
under manuscript preparation
Public notes

Contacts
Principal investigator
Name 32217 0
Prof Woo Seog Sim
Address 32217 0
50 Ilwon dong, Gangnam gu, 135-710 Samsung Seoul Hospital
Country 32217 0
Korea, Republic Of
Phone 32217 0
+82-3410-2470
Fax 32217 0
Email 32217 0
anesthe@skku.edu
Contact person for public queries
Name 15464 0
Dr Sang Hyun Lee
Address 15464 0
50 Ilwon dong, Gangnam gu, 135-710
Samsung Seoul Hospital
Country 15464 0
Korea, Republic Of
Phone 15464 0
+82-2-3410-2470
Fax 15464 0
Email 15464 0
shsara.lee@gmail.com
Contact person for scientific queries
Name 6392 0
Prof Woo Seog Sim
Address 6392 0
50 Ilwon dong, Gangnam gu, 135-710
Samsung Seoul Hospital
Country 6392 0
Korea, Republic Of
Phone 6392 0
+82-2-3410-1935
Fax 6392 0
Email 6392 0
anesthe@skku.edu

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary